The drug: Tofacitinib
The disease: Rheumatoid arthritis
The developer: Pfizer
Peak sales potential: $2 billion to $3 billion

A few weeks ago, the FDA decided to delay the PDUFA date on tofacitinib, Pfizer's ($PFE) big shot at the rheumatoid arthritis market. A big majority of the agency's outside experts already signed off on tofacitinib--an oral JAK inhibitor--back in May, leaving a strong prospect for an approval. Pfizer's chances of success at the FDA have also been bolstered recently by fresh data that demonstrated a reduction in structural bone damage among patients.

Pfizer needs all the positive data it can muster to make its case with payers, which will be looking for solid evidence that the drug is better than what's already on the market. Pfizer responds with the boast that it has one of the biggest data sets ever assembled in RA. And it has good midstage data on ulcerative colitis, which indicates that this treatment has the potential to expand its label into significant new markets.

The FDA is slated to make its decision by November 21. An approval, especially if Eliquis gets a nod soon, would go a long way to help Pfizer make the case that its R&D division is making a comeback--even after the big "bapi" fiasco.

For more:
FDA pushes back PDUFA date on crucial Pfizer app for tofacitinib
Promising colitis data build blockbuster case for Pfizer's tofacitinib
Pfizer faces delay on tofacitinib as new data adds blockbuster luster
Payers likely to throw up hurdles to Pfizer's new RA drug


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